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Guided Internet-delivered Cognitive-behavioral Therapy for Former Chronic Pain Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gerhard Andersson, Linkoeping University
ClinicalTrials.gov Identifier:
NCT01491269
First received: December 7, 2011
Last updated: December 11, 2011
Last verified: December 2011
  Purpose

The aim of the present study was to investigate if guided Internet-delivered Cognitive-behavioral Therapy (CBT) would help chronic pain patients who had previously undergone a multidisciplinary treatment but still have residual problems.


Condition Intervention
Chronic Pain
Behavioral: Guided Internet-based cognitive behavioural treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Guided Internet-delivered Cognitive-behavioral Therapy for Former Chronic Pain Patients: Randomised Controlled Trial

Resource links provided by NLM:


Further study details as provided by Linkoeping University:

Primary Outcome Measures:
  • The Coping Strategies Questionnaire (CSQ) [ Time Frame: One week pre treatment, one week post treatment ] [ Designated as safety issue: No ]
    The CSQ contains 50 items divided in eight scales that measures different cognitive and behavioral coping strategies. The different coping strategies are: diverting attention, re-interpreting pain sensations, coping self-statements, ignoring sensations, praying and hoping, catastrophizing, increased behavioral activities and pain behavior (Rosenthiel & Keefe, 1983). Change from baseline in the different subscales pre- and post treatment.


Secondary Outcome Measures:
  • Hospital Anxiety and Depression Scale, HADS [ Time Frame: One week pre treatment, one week post treatment ] [ Designated as safety issue: No ]
    HADS is a 14-item questionnaire, and is designed to measure anxiety and depression in non-psychiatric patients.

  • Multidimensional Pain Inventory, MPI [ Time Frame: One week pre treatment, one week post treatment ] [ Designated as safety issue: No ]
    MPI, assess psychosocial and behavioural consequences of pain. It´s divided into 2 sections and consisting of 8 scales. These are: Pain Severity, Interference, Life Control, Affective Distress, Support, Punishing Responses, Solicitous Responses and Distracting Responses.

  • Pain and Impairment Relationship Scale (PAIRS) [ Time Frame: One week pre treatment, one week post treatment ] [ Designated as safety issue: No ]
    PAIRS consist of 15 personal statements that reflect thoughts, attitudes and opinions about pain. The questionnaire assesses beliefs and attitudes that patients have regarding pain and ability to function despite discomfort.

  • Quality of Life Inventory (QOLI) [ Time Frame: One week pre treatment, one week post after treatment ] [ Designated as safety issue: No ]
    QOLI contains 32 items for assessing life satisfaction. The assessment yields an overall score and profile in 16 areas of life; health, self-esteem, goals and values, money, work, play, learning, creativity, helping, love, friends, children, relatives, home, neighborhood and community. Each item is rated in terms of importance and satisfaction.

  • Chronic Pain Acceptance Questionnaire (CPAQ) [ Time Frame: One week pre treatment, one week post treatment ] [ Designated as safety issue: No ]
    CPAQ contains 20 items divided in two scales, engagement and willingness. CPAQ measures acceptance in relation to chronic pain.


Enrollment: 72
Study Start Date: August 2009
Study Completion Date: June 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Internet delivered CBT
Internet delivered cognitive behavioral intervention, 8 weeks treatment.
Behavioral: Guided Internet-based cognitive behavioural treatment
Eight weeks internet-based cognitive behavioural treatment. Treatment consisted of education, cognitive skills acquisition, behavioural rehearsal, generalization and maintenance.
No Intervention: Control condition
Active wait-list condition. Were offered to participate in a moderated online discussion forum. After post-treatment assessment the control group were offered treatment.
Behavioral: Guided Internet-based cognitive behavioural treatment
Eight weeks internet-based cognitive behavioural treatment. Treatment consisted of education, cognitive skills acquisition, behavioural rehearsal, generalization and maintenance.

Detailed Description:

The present study investigates Internet-delivered CBT as a tertiary intervention. This is motivated by the fact that many pain patients relapse after rehabilitation and some may be in need of additional treatment. The persons who fulfills the inclusion criteria undergoes a structured telephone interview. The study is a experimental design with a treatment and an active control group measured before and after a treatment period. The control group were invited to participate in a moderated online discussion forum. Follow up data was collected six months after the treatment.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • to have been medically investigated (within one year)
  • completed the multidisciplinary rehabilitation program
  • have residual symptoms after the rehabilitation treatment (defined as functional impairment caused by their pain)
  • have Internet access

Exclusion Criteria:

  • planned surgery
  • ongoing medical investigation that could impede participation in the study
  • suffering from acute physical or psychological conditions
  • people confined to wheelchairs
  • people not fluent with the Swedish language
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01491269

Locations
Sweden
Uppsala University
Uppsala, Sweden
Sponsors and Collaborators
Gerhard Andersson
Investigators
Study Director: Gerhard Andersson, Professor Linköping university
Principal Investigator: Monica Buhrman, MSc Uppsala University
Study Chair: Timo Hursti, PhD Uppsala University
Study Chair: Torsten Gordh, Professor Uppsala University
Study Chair: Anna Fredriksson, MSc Uppsala University
Study Chair: Gunnel Edström, MSc Uppsala University
Study Chair: Dorna Shaffi, MSc Uppsala University
Study Chair: Carolina Törnqvist, MSc Uppsala University
Study Chair: Brjann Ljotsson, PhD Karolinska Institutet, Stockholm
  More Information

No publications provided

Responsible Party: Gerhard Andersson, professor, Linkoeping University, Linkoeping University
ClinicalTrials.gov Identifier: NCT01491269     History of Changes
Other Study ID Numbers: smartaMB2011
Study First Received: December 7, 2011
Last Updated: December 11, 2011
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Linkoeping University:
chronic pain
internet delivered CBT
tertiary intervention
mindfulness
applied relaxation
guided self help

Additional relevant MeSH terms:
Chronic Pain
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on November 25, 2014